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New treatment option for Stroke Hemorrhagic
Official title Rapid Evacuation and Access of Cerebral Hemorrhage Trial
ClinicalTrials.gov ID: NCT06870812
What this study is testing
- What it's testing
- The main purpose of this study is to compare patients with a deep bleed in the brain undergoing surgery to patients receiving routine medical care. The standard treatment involves admission to the Intensive Care Unit (ICU) with close monitoring and blood pressure control.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18-70 years
- Pre-randomization head CT demonstrating an acute, spontaneous, anterior basal ganglia primary intracerebral hemorrhage (ICH) (the anterior basal...
- ICH volume between 20 - 80 mL as calculated by an approved and standardized volumetric measurement
- Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the onset is unclear, then the onset will be...
- Glasgow Coma Score (GCS) 5 - 14
You likely can't join if
- Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic...
- NIH Stroke Scale (NIHSS) less than or equal to 5
- Bilateral fixed dilated pupils
- Extensor motor posturing
- Intraventricular extension of the hemorrhage is visually estimated to involve greater than 50% of either of the lateral ventricles
- Primary thalamic ICH or basal ganglia hemorrhage with involvement \> 25% of thalamus
See the full eligibility criteria
- Age 18-70 years
- Pre-randomization head CT demonstrating an acute, spontaneous, anterior basal ganglia primary intracerebral hemorrhage (ICH) (the anterior basal ganglia include the caudate, putamen, and pallidum to the capsula externa...
- ICH volume between 20 - 80 mL as calculated by an approved and standardized volumetric measurement
- Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the onset is unclear, then the onset will be considered the time that the subject was last known to be well.
- Glasgow Coma Score (GCS) 5 - 14
- Historical Modified Rankin Score 0 or 1
- Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (less than 1 year)...
- NIH Stroke Scale (NIHSS) less than or equal to 5
- Bilateral fixed dilated pupils
- Extensor motor posturing
- Intraventricular extension of the hemorrhage is visually estimated to involve greater than 50% of either of the lateral ventricles
- Primary thalamic ICH or basal ganglia hemorrhage with involvement \> 25% of thalamus
- Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar
- Use of anticoagulants that cannot be rapidly reversed (i.e., criteria is met if investigators are confident that clinically significant coagulopathy is not present after targeted correction)
- Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site
- Uncorrected coagulopathy or known clotting disorder
- Known platelet count less than 75,000 or known international normalized ratio (INR) greater than 1.4 after correction
- Patients requiring long-term anti-coagulation that needs to be initiated less than or equal to 5 days from initial ICH
- End-stage renal disease
- Patients with a mechanical heart valve
- End-stage liver disease
- History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Positive urine or serum pregnancy test in female people without documented history of surgical sterilization or post-menopausal
- Known life expectancy of less than 6 months before ICH
- No reasonable expectation of recovery, do-not-resuscitate (DNR), or comfort measures only before randomization
- Participation in a concurrent treatment medical investigation or clinical trial. Patients in non-treatment/observational studies are eligible
- Inability or unwillingness of the subject or legal guardian/representative to give written informed consent
- Homelessness or inability to meet follow-up requirements
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Palo Alto, California, United States
- Jacksonville, Florida, United States
- Kendall, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Evanston, Illinois, United States
- Carmel, Indiana, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Columbia, Missouri, United States
- Albany, New York, United States
- Syracuse, New York, United States
- The Bronx, New York, United States
- Columbus, Ohio, United States
- Toledo, Ohio, United States
- Providence, Rhode Island, United States
- Nashville, Tennessee, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Palo Alto, California, United States; Jacksonville, Florida, United States; Kendall, Florida, United States; Miami, Florida, United States; Atlanta, Georgia, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.